Generic Ibsrela Availability
Last updated on Apr 10, 2025.
Ibsrela is a brand name of tenapanor, approved by the FDA in the following formulation(s):
IBSRELA (tenapanor hydrochloride - tablet;oral)
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Manufacturer: ARDELYX INC
Approval date: September 12, 2019
Strength(s): EQ 50MG BASE [RLD]
Is there a generic version of Ibsrela available?
No. There is currently no therapeutically equivalent version of Ibsrela available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ibsrela. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent 12,016,856
Issued: June 25, 2024
Inventor(s): Charmot; Dominique et al.
Assignee(s): Ardelyx, Inc. (Fremont, CA)The present disclosure is directed to compounds and methods for the treatment of disorders associated with fluid retention or salt overload, such as heart failure (in particular, congestive heart failure), chronic kidney disease, end-stage renal disease, liver disease, and peroxisome proliferator-activated receptor (PPAR) gamma agonist-induced fluid retention. The present disclosure is also directed to compounds and methods for the treatment of hypertension. The present disclosure is also directed to compounds and methods for the treatment of gastrointestinal tract disorders, including the treatment or reduction of pain associated with gastrointestinal tract disorders. The methods generally comprise administering to a mammal in need thereof a pharmaceutically effective amount of a compound, or a pharmaceutical composition comprising such a compound, that is designed to be substantially active in the gastrointestinal (GI) tract to inhibit NHE-mediated antiport of sodium ions and hydrogen ions therein. More particularly, the method comprises administering to a mammal in need thereof a pharmaceutically effective amount of a compound, or a pharmaceutical composition comprising such a compound, that inhibits NHE-3, -2 and/or -8 mediated antiport of sodium and/or hydrogen ions in the GI tract and is designed to be substantially impermeable to the layer of epithelial cells, or more specifically the epithelium of the GI tract. As a result of the compound being substantially impermeable, it is not absorbed and is thus essentially systemically non-bioavailable, so as to limit the exposure of other internal organs (e.g., liver, heart, brain, etc.) thereto. The present disclosure is still further directed to a method wherein a mammal is administered such a compound with a fluid-absorbing polymer, such that the combination acts as described above and further provides the ability to sequester fluid and/or salt present in the GI tract.
Patent expiration dates:
- December 30, 2029✓✓
- December 30, 2029
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Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent 8,541,448
Issued: September 24, 2013
Inventor(s): Charmot Dominique & Jacobs Jeffrey W. & Leadbetter Michael Robert & Navre Marc & Carreras Christopher & Bell Noah
Assignee(s): Ardelyx, Inc.The present disclosure is directed to compounds and methods for the treatment of disorders associated with fluid retention or salt overload, such as heart failure (in particular, congestive heart failure), chronic kidney disease, end-stage renal disease, liver disease, and peroxisome proliferator-activated receptor (PPAR) gamma agonist-induced fluid retention. The present disclosure is also directed to compounds and methods for the treatment of hypertension. The present disclosure is also directed to compounds and methods for the treatment of gastrointestinal tract disorders, including the treatment or reduction of pain associated with gastrointestinal tract disorders.
Patent expiration dates:
- August 1, 2033✓✓
- August 1, 2033
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Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent 8,969,377
Issued: March 3, 2015
Inventor(s): Bell Noah & Carreras Christopher & Charmot Dominique & Jacobs Jeffrey W & Leadbetter Michael Robert & Navre Marc
Assignee(s): Ardelyx, Inc.The present disclosure is directed to compounds of the structure (X):
Patent expiration dates:
- December 30, 2029✓✓
- December 30, 2029
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Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
Patent 9,006,281
Issued: April 14, 2015
Inventor(s): Bell Noah & Carreras Christopher & Charmot Dominique & Jacobs Jeffrey W & Leadbetter Michael Robert & Navre Marc
Assignee(s): Ardelyx, Inc.The present disclosure is directed to compounds and methods for treating irritable bowel syndrome, chronic kidney disease and end stage renal disease by administering to a subject in need thereof a compound or a pharmaceutically acceptable salt thereof, wherein the compound has the structure
Patent expiration dates:
- May 2, 2030✓
- May 2, 2030
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Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder
Patent 9,408,840
Issued: August 9, 2016
Inventor(s): Bell Noah & Carreras Christopher & Charmot Dominique & Jacobs Jeffrey W. & Leadbetter Michael Robert & Navre Marc
Assignee(s): Ardelyx, Inc.The present disclosure is directed to compounds of the structure (X): CoreL-NHE) (X) wherein:
Patent expiration dates:
- December 30, 2029✓
- December 30, 2029
More about Ibsrela (tenapanor)
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- Drug class: NHE3 inhibitors
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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